In San Francisco, HIV infection rates among men who have tested for HIV three or more times is almost triple the HIV infection rates of all other testers. Past research has shown that HIV uninfected gay and bisexual men who receive counseling are less likely to engage in high-risk sexual behavior. Counseling provided by trained mental health professionals within a clinical study setting helped individuals identify and re-evaluate their "self-justifications," which are their thoughts, attitudes, and beliefs when deciding to engage in unprotected sex. This study will focus on implementing a "real-world" counseling intervention designed specifically for men who are at the greatest risk of becoming infected with HIV: men who engage in high-risk sexual activity with other men and who repeatedly test for HIV. This specialized intervention will be administered by trained paraprofessional counselors during a pre-test counseling session prior to an HIV test. The purpose of this study is to evaluate the effectiveness of the specialized pre-test counseling intervention versus a standard pre-test counseling intervention in promoting safer sexual activity among HIV uninfected men. The men will have reported having unprotected sex with males of unknown HIV status or known HIV infection.

This 12-month study will enroll 300 men who will be recruited upon scheduling an anonymous HIV test at the participating clinic. Participants will be randomly assigned to receive either the enhanced pre-test counseling session or a standard pre-test counseling session prior to an HIV test. Outcome measurements will be assessed 6 and 12 months after the counseling session and will include self-reports of unprotected anal sex with non-primary partners and reported satisfaction levels with the pre-test counseling.

Eligibility

Ages Eligible for Study:

18 Years and older (Adult, Senior)

Genders Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

History of two or more HIV antibody tests prior to study entry

History of at least one episode of unprotected anal intercourse (receptive or insertive) within 12 months prior to study entry

Exclusion Criteria:

History of injection drug use within 12 months of study enrollment

Insufficient proficiency in English

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00218699

Locations

United States, California

UCSF AIDS Health Project

San Francisco, California, United States, 94102

Sponsors and Collaborators

University of California, San Francisco

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

James W. Dilley, MD

UCSF AIDS Health Project

Principal Investigator:

William J. Woods, PhD

UCSF Center for AIDS Prevention Studies

More Information

Responsible Party:

James W. Dilley, MD/Principal Investigator, University of California, San Francisco - Department of Psychiatry